Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice

Epicondylitis Clinical Trial

Official title:

Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552235
• Other study ID #: elbowSOFT300
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: March 2023

Study information

• Verified date: January 2023
• Source: Decathlon SE
• Contact: Jean HEE
• Phone: 07 64 35 00 45
• Email: jean.hee[@]btwin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability.

The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Elbow soft 300 product to demonstrate safety and performance of this device in a real-world setting.

Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon ElbowSoft300 device and support peer-reviewed publications on products performance and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Subject is aged = 18 years old

• Subject has a chronic epicondylitis (>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (>3 months)

• The current condition of his/her elbow allows the subject to continue usual physical activity

• Subject has been informed and is willing to sign an informed consent form

• Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)

• Subject is affiliated to the French social security regime

Exclusion Criteria:

• Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent

• Subject has worn a support (elbow brace or articulated orthosis) in the last month during his/her sport practice

• Subject has any medical condition that could impact the study at investigator's discretion

• Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, polyester, elastane)

• Adult subject to legal protection measure

Related Conditions & MeSH terms

• Elbow Injury
• Epicondylitis
• Tendinopathy
• Wounds and Injuries

Intervention

Device:
• Elbow SOFT 300
15 patients will be included in this group and will used the medical device ElbowSOFT 300 during sport practice (at least 2 sport sessions per week), for 6 weeks.

Other:
• Control group
15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device), for at least 2 sport sessions per week during 6 weeks.

Locations

Country	Name	City	State
France	Centre Hospitalier de Boulogne-sur-Mer	Boulogne-sur-Mer
France	Centre Hospitalier Universitaire de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Decathlon SE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functionnal score	Comparison of the Patient Rated Elbow Evaluation (20-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control)	Change from Baseline functionnal score at 6 weeks
Secondary	Confidence level (confidence questionnaire related to physical activity)	Gap in the confidence level related to physical activity (6-item questionnaire with a global score from 0=worst outcome to 100=best outcome), between the baseline and last follow-up visit in each group (orthosis vs control)	Change from Baseline confidence level at 6 weeks
Secondary	Elbow pain	Comparison of elbow pain, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control)	Change from Baseline elbow pain at 6 weeks
Secondary	Elbow instability	Comparison of elbow instability, assessed through a Numerical Rating Scale (NRS) ranging from 0=best outcome to 10=worst outcome, between the groups (orthosis vs control)	Change from Baseline elbow instability at 6 weeks
Secondary	Safety (adverse events)	Comparison of adverse events rates between the groups (orthosis vs control)	6 weeks of follow-up